510(k) Report

510(k) · Cleared

Cleared

Microgyn II Elec Stim Device Treat of Urin Inconti

K891773510(k) TraditionalCleared Aug 23, 1989152-day reviewClass II21 CFR 876.5320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Cleared on Aug 23, 1989 after a 152-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
Aug 23, 1989
Review
152 days
Class
Class II
Product code
KPI
Recalls
None
Predicates
0

50 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1997: 8 descendants cleared1999: 1 descendant cleared2000: 1 descendant cleared1998: 2 descendants cleared2003: 2 descendants cleared2001: 1 descendant cleared2016: 3 descendants cleared2013: 1 descendant cleared2008: 1 descendant cleared2022: 1 descendant cleared2015: 2 descendants cleared2021: 1 descendant cleared2002: 3 descendants cleared2024: 2 descendants cleared2020: 1 descendant cleared2025: 3 descendants cleared2018: 2 descendants cleared2004: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant cleared2026: 6 descendants cleared2023: 3 descendants cleared1990200020102020
  1. This deviceK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
  2. Descendant · cites it directly · 30 of its ownK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
  3. Descendant · cites it directly · 26 of its ownK963222 Microgyn Plus Stimulation DeviceHollister, Inc. · 1996
  4. Descendant · 2 generations on · 14 of its ownK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
  5. Descendant · 2 generations on · 13 of its ownK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
  6. Descendant · 3 generations on · 12 of its ownK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1996: 31997: 81998: 21999: 12000: 12001: 12002: 32003: 22004: 12008: 12013: 12015: 22016: 32017: 12018: 22019: 12020: 12021: 12022: 12023: 32024: 22025: 32026: 6
1996high 8 (1997) · low 0 (2005)2026

Most influential descendants

Showing 5 of 50 · See all
  • K960496Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996 · cites it directly30descendants
  • K963222Microgyn Plus Stimulation DeviceHollister, Inc. · 1996 · cites it directly26descendants
  • K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003 · 2 generations on14descendants
  • K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003 · 2 generations on13descendants
  • K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008 · 3 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891773Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc.1989—
+1K960496Liberty Lite PFS SystemUtah Medical Products, Inc.1996—
+1K963222Microgyn Plus Stimulation DeviceHollister, Inc.1996—
+2K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.2003—
+2K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.2003—
+3K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199780
199820
199910
200010
200110
200230
200320
200410
200810
201310
201520
201630
201710
201820
201910
202010
202110
202210
202330
202420
202530
202660
FIG. 1 — Lineage of K891773, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KPI device

  1. #1 K262353 BTL-299-Fscore 14.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (50)

See all 50

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960496Liberty Lite PFS SystemUtah Medical Products, Inc.199630
K963222Microgyn Plus Stimulation DeviceHollister, Inc.199626
K970307Minnova Pelvic Floor Stimulation SystemEmpi199712
K970602Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc.19977
K954272Innova Rectal Stimulaton ElectrodeEmpi19967
K990456Anal 2 Electrode Stimulation/Emg Probe - W/StopHollister, Inc.19996
K971541Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc.19976
K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group20000
K964526Liberty Rectal Pelvic Floor ExerciserUtah Medical Products, Inc.19970

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K960496 (Utah Medical Products, Inc., 1996) has gone furthest, with 30 descendants of its own.

How does its category compare?

All KPI devices

KPI Stimulator, Electrical, Non-Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPI

7so far in 2026, the most since 2007

2007: 12008: 12009: 22011: 12012: 22013: 12014: 32015: 62016: 32017: 12018: 32019: 22020: 12021: 32022: 32023: 32024: 42025: 42026 (partial year): 7
2007high 7 (2026) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPI

263in 2025

2014: 57 days median2015: 260 days median2016: 89 days median2018: 304 days median2021: 217 days median2022: 181 days median2023: 197 days median2024: 172 days median2025: 263 days median2026 (partial year): 248 days median
2007high 304 (2018) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPI

No recall names KPI since 2007.

Adverse event reports per year · KPI

2in 2024

2013: 12015: 22017: 42019: 22020: 32021: 12022: 22023: 62024: 2
2007high 6 (2023) · low 0 (2007)2025

MAUDE reports naming product code KPI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20092—00
20100—00
20111—00
20122—00
20131—01
201435700
2015626002
201638900
20171—04
2018330400
20192—02
20201—03
2021321701
2022318102
2023319706
2024417202
2025426300
202672480—

More from Hollister, Inc.

85 FDA decisions under this applicant name. See the company

  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144…Hollister, Inc. · 2009
  • K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005

Recent decisions in KPI

The KPI category page

  • K262353BTL-299-FBTL Industries, Inc. · 2026
  • K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
  • K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle…Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
  • K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd. · 2026
  • K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K891773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K891773: Microgyn II Elec Stim Device Treat of Urin Inconti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891773

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026